Imaging Characterization of the Biomechanical Coupling of Brain and Skull: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Obtain MRE images
研究概览
简要总结
Background:
Traumatic brain injury (TBI) affects over 1.7 million people in the United States each year. Many cases are mild, but people with a history of TBI may have long-term symptoms; they are also known to be more susceptible to future concussions. Researchers are working to understand how TBI affects tissues in and around the brain over the long term. This natural history study will investigate how a TBI may change the stiffness of the brain and its surrounding connective tissues.
Objective:
To see how the brain and connective tissues respond to small head movements in people with and without a prior TBI.
Eligibility:
People aged 21 to 65 years with a history of TBI. People with no history of TBI are also needed.
Design:
Participants will have 1 clinic visit that will last about 4 hours.
Participants will have a physical exam. They answer questions to make sure it is safe for them to have a magnetic resonance imaging (MRI) scan of their brain.
They will have an MRI scan in 2 parts.
During the first part, participants will lie on a table that slides into a large tube. They will hear loud knocking noises. They may wear earplugs or earmuffs. They will lie still for 15 minutes at a time. They will be in the tube for about up to 75 minutes.
The second part is called magnetic resonance elastography (MRE). Participants will lie with their head on a pillow that vibrates gently. This test will take 10 minutes.
Participants will answer questions about how they feel 1 or 2 days after the procedure.
详细描述
Study Description:
The study will characterize the biomechanical coupling of the brain to the skull in human volunteers with and without a history of traumatic brain injury (TBI) using magnetic resonance elastography (MRE). MRE uses the MR scanner to measure the relative motion of brain and skull while the head is vibrated at specified frequencies.
Objectives:
Our objectives are:
- Apply MRE to characterize the skull-brain interface in 25 mild TBI patients with a history of acute TME (TME+), 25 TME-patients (mild TBI patients without TME) and 25 healthy controls.
- To determine whether local shear strain measures within the cortex during MRE are altered in TME+ subjects. Up to 10 additional healthy controls will be recruited for technical development of imaging protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Obtain MRE images
时间窗: End of study
MRE images will be processed to estimate global differences in the amplitudes and temporal delays of translation and rotation between brain and skull. Temporal delay reflects the lag in motion between the skull and brain, with a lower delay reflecting tighter coupling of motion.
次要结局
- Measure skull brain coupling(End of study)